ClinicalTrials.gg
Not yet recruitingNCT06623643Updated Oct 4, 2024

"Salivary Melatonin and Cortisol Levels in Individuals with Bruxism"

An observational study in Bruxism, sponsored by Yuzuncu Yıl University. Not yet recruiting. Per ClinicalTrials.gov, last updated 2024-10-04.

Sponsored by Yuzuncu Yıl University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
100
Sex
All
01

Study summary

The effects of the hormones melatonin and cortisol, which play a highly effective role in regulating the sleep-wake cycle, on teeth grinding will be scientifically evaluated. Based on the research results, more effective methods for treating patients suffering from bruxism may be identified.

02

Conditions studied

  • Bruxism

Browse trials for

Keywords

  • melatonin
  • saliva
  • cortizol
03

In context

Bruxism

151 studies on the registry are indexed under Bruxism; 39 are open to participants now.

This study's planned enrollment of 100 is above the median of 89 across 55 observational studies indexed under Bruxism.

Browse Bruxism studies →

Lead sponsor

Yuzuncu Yıl University is the lead sponsor of 124 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

ndividuals with and without bruxism

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Individuals without any known hormonal diseases, not using antidepressants or medications that could alter saliva content, without degenerative diseases affecting the salivary glands, without cysts or tumors affecting the temporomandibular region, and not undergoing insomnia treatment will be included in the study

Exclusion criteria

Exclusion Criteria:

  • Individuals with systemic diseases that affect or may potentially affect saliva content, or those using medications that cause these effects, will not be included in the study
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • 1

    Evaluation of Melatonin and Cortisol Levels in Individuals with Bruxism

    Diagnostic Test: The investigation of melatonin and cortisol levels in the saliva

  • 2

    Evaluation of Melatonin and Cortisol Levels in Individuals without Bruxism

    Diagnostic Test: The investigation of melatonin and cortisol levels in the saliva

Interventions

  • Diagnostic testThe investigation of melatonin and cortisol levels in the saliva

    In the related study, patient data from individuals who visited the Oral and Maxillofacial Radiology clinic at Van Yüzüncü Yıl University Faculty of Dentistry with complaints of bruxism will be used. The diagnosis of bruxism will be made based on clinical data. Diagnoses will be made by Dr. Sema KAYA using clinical findings such as patient history used for the current diagnosis of bruxism, tooth wear, tooth mobility, pain in the temporomandibular joint (TMJ), headaches, pain in the chewing muscles, hypertrophy, and a feeling of fatigue. Before taking the saliva samples, patients will be asked to rinse their mouths with sterile water, and then they will be asked to spit into sterile plastic containers. After approximately 3 mL of saliva is collected, it will be transferred to appropriate Eppendorf tubes and stored at -80°C. Melatonin and cortisol levels will later be analyzed using the enzyme-linked immunosorbent assay (ELISA) method.

06

What researchers measure

Primary outcomes

  1. levels of melatonin

    individuals with bruxism

    Time frame: Baseline assessment at the start of the study, follow-up assessments at 3 months and 6 months, with final data collection at 12 months.

  2. levels of cortisol

    individuals with bruxism

    Time frame: Baseline assessment at the start of the study, follow-up assessments at 3 months and 6 months, with final data collection at 12 months.

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2024; primary completion for Dec 2024, 2 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 1, 2024
First posted
Oct 2, 2024
StartEst.
Oct 30, 2024
Primary completionEst.
Dec 30, 2024
CompletionEst.
Feb 28, 2025
Last update
Oct 4, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06623643
Responsible party
sema kaya (doctor, Yuzuncu Yıl University) — Principal investigator
First posted
Oct 2, 2024
Start date
Oct 30, 2024 (estimated)
Primary completion
Dec 30, 2024 (estimated)
Completion
Feb 28, 2025 (estimated)
Last update
Oct 4, 2024

Study contacts

Sema Kaya
Contact
semakaya@yyu.edu.tr
+90 432 225 17 22 ext. +905540062682

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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